Drugs / Granulocyte colony-stimulating factor
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Granulocyte colony-stimulating factor

Protein / enzyme biologic

Developed for
acute myeloid leukemia · myocardial infarction · acute myocardial infarction · alcoholic hepatitis · amyotrophic lateral sclerosis · biliary atresia · cerebral palsy · Chagas cardiomyopathy
+16 more · dilated cardiomyopathy · epidermolysis bullosa dystrophica · hematopoietic and lymphoid system neoplasm · hemopoietic proliferation · hepatitis B virus infection · liver failure · myelodysplastic syndrome · neutropenia · stroke disorder · symptomatic heart failure · type 1 diabetes mellitus · uterine disorder · aplastic anemia · cirrhosis of liver · fungal infectious disease · liver disorder
Investigated by
Barts & The London NHS Trust · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Seoul National University Hospital · American Diabetes Association · Amgen · Assistance Publique - Hôpitaux de Paris
+45 more · Beijing 302 Hospital · Beike Biotech India Pvt.ltd · Canadian Institutes of Health Research (CIHR) · Chinese PLA General Hospital · Else Kröner Fresenius Foundation · Emory University · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · EuroFancolen · First Affiliated Hospital of Zhejiang University · First People's Hospital of Chenzhou · German Heart Center Munich · Hanyang University Seoul Hospital · Hospital Sao Rafael · Huihan Wang · Institute of Hematology & Blood Diseases Hospital, China · Jining Medical University · Juvenile Diabetes Research Foundation · Liuzhou Workers' Hospital · Ministry of Health & Welfare, Korea · Nanfang Hospital, Southern Medical University · Nanjing University · National Center for Research Resources (NCRR) · National Institute of Allergy and Infectious Diseases (NIAID) · National Liver Institute, Egypt · Navy General Hospital, Beijing · Peking University People's Hospital · Post Graduate Institute of Medical Education and Research, Chandigarh · Rigshospitalet, Denmark · Ruijin Hospital · Sanofi · Schering-Plough · Schulz Foundation · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · The First Affiliated Hospital of Soochow University · The First Affiliated Hospital of Zhengzhou University · The Leona M. and Harry B. Helmsley Charitable Trust · Tongji Hospital · URC-CIC Paris Descartes Necker Cochin · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · University Hospital Muenster · University of Ottawa · Vanderbilt University Medical Center · Weill Medical College of Cornell University · Wilhelm Sander Foundation

Trials 26

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/24 trials
Phase 1/2 NCT02678533 Feb 2017 → Nov 2018 Fanconi anemia Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 1/2 NCT02886559 Jun 2016 → Jun 2018 acute myeloid leukemia Chinese PLA General Hospital Unknown No outcome recorded
Phase 1/2 NCT02983708 Aug 2011 → Sep 2014 cerebral palsy, neurodegenerative disease Hanyang University Seoul Hospital Completed No outcome recorded
Phase 1/2 NCT00922389 Jul 2009 → Jan 2010 limb ischemia, ulcer of lower limbs Beike Biotech India Pvt.ltd Unknown No outcome recorded
Phase 28 trials · 1 missed
Phase 2 NCT03572660 Dec 2018 → Mar 2030 expected dilated cardiomyopathy Barts & The London NHS Trust Active not recruiting No outcome recorded
Phase 2 NCT03985007 Jan 2018 → Dec 2020 acute myeloid leukemia The First Affiliated Hospital of Soochow University Completed No outcome recorded
Phase 2 NCT02154269 Sep 2015 → Oct 2019 Chagas cardiomyopathy Hospital Sao Rafael Completed Missed primary
Phase 2 NCT02215200 Dec 2014 → Aug 2017 type 1 diabetes mellitus National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed Mixed
Phase 2 NCT01538862 Feb 2012 → Oct 2014 epidermolysis bullosa dystrophica Vanderbilt University Medical Center Completed No outcome recorded
Phase 2 NCT00298597 Mar 2006 → Mar 2009 amyotrophic lateral sclerosis, stroke disorder University Hospital Muenster Completed No outcome recorded
Phase 2 NCT00307879 Mar 2004 → Feb 2005 myocardial infarction Seoul National University Hospital Terminated No outcome recorded
Phase 2 NCT00135928 May 2003 → Feb 2006 acute myocardial infarction Rigshospitalet, Denmark Completed No outcome recorded
Phase 2/34 trials · 1 met primary
Phase 2/3 NCT02744742 Apr 2016 → Sep 2019 disease related to hematopoietic stem cell transplant, myelodysplastic syndrome Nanfang Hospital, Southern Medical University Completed Met primary
Phase 2/3 NCT00501917 Mar 2007 → Feb 2010 acute myocardial infarction Seoul National University Hospital Unknown No outcome recorded
Phase 2/3 NCT00394498 Sep 2005 → Oct 2006 myocardial infarction University of Ottawa Unknown No outcome recorded
Phase 2/3 NCT00747708 Aug 2005 → May 2012 symptomatic heart failure Barts & The London NHS Trust Completed No outcome recorded
Phase 32 trials
Phase 3 NCT07692672 Oct 2026 → Aug 2029 expected female infertility, uterine disorder Nanjing University Not yet recruiting No outcome recorded
Phase 3 NCT00005782 Jan 2000 → Jul 2002 inherited hemoglobinopathy National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed No outcome recorded
Phase 44 trials · 1 met primary · 1 missed
Phase 4 NCT02971306 Jul 2014 → Dec 2017 alcoholic hepatitis Post Graduate Institute of Medical Education and Research, Chandigarh Unknown Met primary
Phase 4 NCT02331745 Oct 2013 → Apr 2016 alcoholic liver disease, hepatitis B virus infection, liver failure Beijing 302 Hospital Unknown No outcome recorded
Phase 4 NCT00126100 Feb 2004 → Jul 2005 myocardial infarction German Heart Center Munich Completed Missed primary
Phase 4 NCT00194857 Feb 2002 → Dec 2005 HIV infectious disease, anemia, chronic hepatitis C virus infection, neutropenia Weill Medical College of Cornell University Terminated No outcome recorded
Phase not applicable4 trials
— NCT07423728 Mar 2026 → Mar 2027 expected hemopoietic proliferation First Affiliated Hospital of Zhejiang University Recruiting No outcome recorded
— NCT06708572 Dec 2024 → Oct 2026 expected biliary atresia National Liver Institute, Egypt Recruiting No outcome recorded
— NCT04168138 Nov 2019 → Dec 2021 acute myeloid leukemia Huihan Wang Unknown No outcome recorded
— NCT00231309 Jul 2003 → Nov 2011 hematopoietic and lymphoid system neoplasm Emory University Completed No outcome recorded
Comparator or background therapy73 trials
Phase 0 NCT02851056 Background Sep 2016 → Jul 2018 plasma cell myeloma H. Lee Moffitt Cancer Center and Research Institute Completed No outcome recorded
Phase 1 NCT06509906 Background Oct 2024 → Dec 2025 neoplasm EMD Serono Research & Development Institute, Inc. Terminated No outcome recorded Stop: Business
Phase 1 NCT06001788 Background Feb 2024 → Aug 2026 overdue acute myeloid leukemia with mutated NPM1, acute myeloid leukemia, MLL gene rearrangement Kura Oncology, Inc. Recruiting No outcome recorded
Phase 1 NCT03909412 Background Oct 2019 → Aug 2027 expected plasma cell myeloma Hackensack Meridian Health Recruiting No outcome recorded
Phase 1 NCT00686556 Background Aug 2012 → Nov 2016 acute lymphoblastic leukemia, myelodysplastic syndrome, plasma cell myeloma Masonic Cancer Center, University of Minnesota Completed No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2026-01-09 Assertio Holdings, Inc Results Assertio Announces Publication of Rolvedon® Same-Day Dosing Clinical Trial assertiotx.com ↗
Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT) today announced that results of a clinical trial investigating a novel dosing schedule of Rolvedon® (eapegrastim-xnst) injection have been peer reviewed and published in The Oncologist.
2012-08-30 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces FDA Grants Approval for Tbo-filgrastim for the Treatment of Chemotherapy-Induced Neutropenia tevapharm.com ↗
2010-02-02 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces FDA Accepts BLA for XM02 tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva's Biologics License Application (BLA) for XM02
2009-12-01 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces The Submission Of A Biologics License Application (BLA) For XM02 For The Treatment Of Chemotherapy-Induced Neutropenia tevapharm.com ↗

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 111 sources stand behind the page.

FieldValueCited text
Known as granulocyte-colony stimulating factor “Before treatment initiation, subjects were randomized to subsequently receive growth factors, recombinant human erythropoietin (rHuEPO) and/or granulocyte colony-stimulating...” PMID 21876446 ↗ Nov 2011
100

“This study will examine the effects of granulocyte colony-stimulating factor (G-CSF) on bone marrow stem cells in healthy volunteers with sickle cell trait and determine if...” NCT00005782 ↗

“This multicenter clinical trial evaluated the safety and efficacy of epigenetic modifiers (chidamide and decitabine) in combination with aclarubicin, cytarabine, and...” PMID 32873343 ↗ Sep 2020

“administration of cytokines like granulocyte-colony stimulating factor (G-CSF) and the other is the isolation of stem cells from the marrow and their injection into the hepatic...” NCT03911037 ↗

“After 5 days of granulocyte colony-stimulating factor therapy and a subsequent bone marrow aspiration, patients undergo an intracoronary infusion of autologous...” PMID 37190883 ↗ May 2023

“Administration of a combination of two drugs, granulocyte colony-stimulating factor (G-CSF) and dexamethasone, has been show to stimulate the body to produce a large number of...” NCT00627393 ↗

“Plerixafor used in combination with G-CSF (Granulocyte Colony Stimulating Factor) in 5 Fanconi anemia patients to mobilize and collect a sufficient number of peripheral blood...” NCT02678533 ↗

“* Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg/day beginning on Day 5 until absolute neutrophil count (ANC) is greater than or equal to 1,000/mm\^3 for 3 consecutive days” NCT00849147 ↗

“We evaluated the role of granulocyte colony-stimulating factor (G-CSF) in patients with severe aplastic anemia (SAA) treated with antithymocyte globulin (ATG) and cyclosporine.” PMID 21233311 ↗ Jan 2011

“This study was designed to evaluate potential clinical benefit of adding Erythropoietin (EPO) in granulocyte-colony stimulating factor (G-CSF)-mobilized stem cell therapy” PMID 29962032 ↗ Aug 2018

“Small studies have yielded divergent results for administration of granulocyte colony-stimulating factor (G-CSF) after acute myocardial infarction.” PMID 24934893 ↗ Jun 2014

Show 90 more sources

Known as G-CSF “* Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg/day beginning on Day 5 until absolute neutrophil count (ANC) is greater than or equal to 1,000/mm\^3 for 3 consecutive days” NCT00849147 ↗
67

“Donors will receive the white cell growth hormone (G-CSF) as a shot (injection) in their arm once a day for three days before they donate their bone marrow cells.” NCT00231309 ↗

“The drug G-CSF, which is a naturally occurring hormone, causes stem cells to mobilize-that is, to be released from the bone marrow and enter the blood stream.” NCT00005782 ↗

“Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 μg/day, continued until neutrophil recovery and white blood cell count is ≥20,000/μL” NCT06928376 ↗

“Small studies have yielded divergent results for administration of granulocyte colony-stimulating factor (G-CSF) after acute myocardial infarction.” PMID 24934893 ↗ Jun 2014

“a growth factor called granulocyte-colony stimulating factor (G-CSF), which is a natural protein that increases the white blood cell count” NCT00864227 ↗

“Granulocyte colony-stimulating factor(G-CSF) was given 5 ug/kg subcutaneously qd for 6 doses,then qod for other 6 doses(total 12 doses).” NCT02331745 ↗

“Granulocyte colony-stimulating factor (G-CSF) is injected into subcutaneous for three days prior to the blood collection (D-3 to D-1).” NCT02315235 ↗

“Mobilization of bone marrow-derived stem cells with granulocyte colony-stimulating factor (G-CSF) could promote hepatic regeneration.” PMID 22119930 ↗ Nov 2011

“Granulocyte colony-stimulating factor (G-CSF; 300mcg/mL) will be administered for 1 day as a single daily subcutaneous dose.” NCT01412593 ↗

“Patients are randomised in a 1:1 ratio to receive granulocyte-colony stimulating factor (G-CSF) or placebo injection” NCT00747708 ↗

Show 57 more sources

Known as G-CSF(granulocyte colony-stimulating factor ) “G-CSF(granulocyte colony-stimulating factor )” NCT02784561 ↗
Known as G-SCF ClinicalTrials.gov intervention name — accepted as the source's own label NCT00040417 ↗
Known as Granulocyte-colony stimulating factors “Granulocyte-colony stimulating factors (G-CSF) can regenerate hepatocyte by fusing with hematopoietic cells” NCT02971306 ↗
Known as Neupogen “Granulocyte Colony Stimulating Factor G-CSF (Neupogen®)” NCT00135928 ↗
Known as rhG-CSF “Recombinant Human Granulocyte Stimulating Factor (rhG-CSF)” NCT01232504 ↗
Modality Protein / enzyme biologic “the growth factor G-CSF has been given to stem cell donors” NCT00082329 ↗
Route Subcutaneous “They will receive injections of G-CSF under the skin once a day for 5 days.” NCT00005782 ↗